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Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.

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I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter granting 510(k) clearance for "Oil for Tissue Culture" and an "Indications For Use" statement. It does not include any technical or performance study details.

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Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.

Quinn's® HTF Medium was developed for in vitro fertilization and procedures involving the culture of early cleavage stage mammalian embryos.

Quinn's® HTF Medium with HEPES was developed for in vitro procedures involving manipulations of gametes and embryos not requiring the use of a CO2 incubator. Such procedures include oocyte recovery, gamete washing, micromanipulation, embryo transfer and cryopreservation.

Quinn's® Basal XI HTF Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos from Day 1 through to Day 3.

Quinn's® D3+ Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos after Day 3 of development.

Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.

This is a 510(k) premarket notification for a medical device called "Media for Embryo Preparation." The provided documents are NOT a study or a report detailing acceptance criteria and device performance. They are regulatory documents from the FDA, specifically:

• Document 0: An FDA letter granting substantial equivalence (510(k) clearance) for the device. This letter indicates that the FDA has reviewed the submission and determined that the device is as safe and effective as a legally marketed predicate device.
• Document 1: The "Indications For Use" statement from the 510(k) submission, outlining the intended purpose of the embryo preparation media.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC study results, etc.) from these documents because they do not contain that type of technical performance data or study report.

To answer your prompt, I would need a different type of document, such as:

• A clinical study report
• A performance testing report
• A validation study report
• The summary of safety and effectiveness (SSE) part of the 510(k) submission, which often includes details on performance data.

Without such a document, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for IUI.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Human Serum Albumin in Normal Saline," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document mentions the "Indications For Use" for Human Serum Albumin, which is a macromolecular supplement used in various assisted reproductive technology (ART) procedures. However, it does not contain the detailed study information, acceptance criteria table, or ground truth establishment methods requested in your prompt.

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Quinn's® Sperm Washing Medium is for in vitro procedures involving sperm washing and incubation.

Quinn's® Sperm Washing Medium

This document is a 510(k) clearance letter for Quinn's® Sperm Washing Medium and an associated "Indications For Use" statement. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot generate the requested table and study details from the provided text.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. The "Indications For Use" states that the medium is for in vitro procedures involving sperm washing and incubation.

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PVP is used for the intracytoplasmic sperm injection (ICSI) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.

PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)

This document is a 510(k) clearance letter for "PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)" for use in ICSI procedures. It's a regulatory approval document and does not contain information about acceptance criteria or specific study details often found in scientific publications or clinical trial reports.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text.

The closest information available is the "Indications For Use," which describes what the device is intended for: to decrease sperm motility, prevent sticking to the injection pipette, and provide more control over fluid flow during ICSI. This is a functional description, not a set of performance metrics or acceptance criteria as you've defined them.

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